The world is currently changing due to coronavirus disease 2019 (COVID-19), and the field of dentistry is no stranger to this. The care of patients in the dental office involves very strict biosafety protocols, and patients must be aware of the protection barriers implemented to allow satisfactory, safe dental care. The purpose of this study was to synthesize and analyze the management of the current biosafety standards for dental patients since the arrival of the COVID-19 pandemic. A bibliographic search of the main sources of information including MEDLINE (by means of PubMed), Scopus, Science Direct, SCIELO, and Google Scholar was carried out. Articles published without language restriction, systematic reviews, literature reviews, and observational studies were included. We identified the biosafety measures that must be taken before, during, and after dental practice following the arrival of COVID-19. The main measures include telephone triage, temperature taking on arrival at the office, the organization of the waiting room, washing hands before entering the office, knowing the auxiliary radiographic exams of choice and what type of treatment can be performed, albeit with restrictions. In conclusion, dental patients must comply with all the biosafety measures established by international protection standards and implemented by dentists before, during, and after dental practice to reduce the possibility of COVID-19 infection.

Nipah virus (NiV) outbreak occurred in Kozhikode district, Kerala, India in 2018 with a case fatality rate of 91% (21/23). In 2019, a single case with full recovery occurred in Ernakulam district. We described the response and control measures by the Indian Council of Medical Research and Kerala State Government for the 2019 NiV outbreak. The establishment of Point of Care assays and monoclonal antibodies administration facility for early diagnosis, response and treatment, intensified contact tracing activities, bio-risk management and hospital infection control training of healthcare workers contributed to effective control and containment of NiV outbreak in Ernakulam.

Increasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Committee (IBC) review is generally required at each separate site. Duplicative review may result in both administrative costs and delays, without evidence of increased safety or protections, and investigator frustration. To address these inefficiencies, IBC leaders drafted a collaborative IBC Reliance Authorization Agreement. The Agreement allows one or more institutions to cede IBC review to a reviewing IBC that accepts the responsibility. The ability to cede IBC review, and the ability to rely on one decision on behalf of all collaborating institutions for a given protocol, removes delays in approval of multi-center protocols, and collaborating principal investigators are able to focus on research rather than administrative tasks. In the process, we found promotion of this collaborative model led to stronger connections among institutions and among IBC members. The requirement for IBC member representation from the local community, however, limits its broader dissemination; we make several recommendations to mitigate this challenge.

This article analyzes the ethics of synthetic biology (synbio) from a consequentialist perspective, examining potential effects on food and agriculture, and on medicine, fuel, and the advancement of science. The issues of biosafety and biosecurity are also examined. A consequentialist analysis offers an essential road map to policymakers and regulators as to how to deal with synbio. Additionally, the article discusses the limitations of consequentialism as a tool for analysing synbioethics. Is it possible to predict, with any degree of plausibility, what the consequences of synthetic biology will be in 50 years, or in 100, or in 500? Synbio may take humanity to a place of radical departure from what is known or knowable.

For some, synthetic biology represents great hope in offering possible solutions to many of the world’s biggest problems, from hunger to sustainable development. Others remain fearful of the harmful uses, such as bioweapons, that synthetic biology can lend itself to, and most hold that issues of biosafety are of utmost importance. In this article, I will evaluate these points of view and conclude that although the biggest promises of synthetic biology are unlikely to become reality, and the probability of accidents is fairly substantial, synthetic biology could still be seen to benefit humanity by enhancing our ethical understanding and by offering a boost to world economy.

The commercialization of imazethapyr-resistant (Clearfield™, CL) rice in the southern United States has raised serious concerns about gene flow to red rice, producing imazethapyr-resistant red rice populations. Our objectives were to determine the impact of planting date, CL cultivars, and red rice biotypes on outcrossing rate; and to investigate the relative contribution of flowering time of CL rice and red rice biotypes, together with air temperature and relative humidity (RH), on outcrossing rate. Field experiments were conducted at Stuttgart, Rohwer, and Kibler, AR, from 2005 to 2007, at three or four planting times from mid-April to late May. ‘CL161’ (inbred cultivar) and ‘CLXL8’ (hybrid) rice were planted in nine-row plots, with red rice planted in the middle row. Twelve red rice biotypes were used. The flowering of red rice and CL rice, air temperature, and RH were recorded. Red rice seeds were collected at maturity. To estimate outcrossing rate, resistance to imazethapyr was evaluated in subsequent years and confirmed using rice microsatellite markers. CLXL8 rice flowered 2 to 4 d earlier than CL161 rice, and flowering was completed within 1 wk in all plantings. The flowering duration of most red rice biotypes ranged from 4 to 17 d. Flowering synchrony of red rice biotypes and CL rice ranged from 0 to 100% at different plantings. In general, CLXL8 had greater flowering overlap and higher outcrossing rate with red rice than did CL161 rice. The outcrossing rate of red rice biotypes ranged from 0 to 0.21% and 0 to 1.26% with CL161 and CLXL8 rice, respectively. The outcrossing rate differed within each planting date (P < 0.05). Outcrossing was generally lower in mid-May and late May than in mid-April and late April planting times. Flowering synchrony and outcrossing rate were not correlated (r2 < 0.01). Outcrossing with CL161 was primarily influenced by red rice biotype. A minimum air temperature of > 24 C in the evening also favors outcrossing with CL161. With CLXL8 rice, outcrossing was most affected by RH. When RH was < 54%, outcrossing was less (0.12%) than when RH was ≥ 54% (0.38%). With CLXL8 rice, a minimum RH of ≥ 54%, from mid-morning to noon, increased outcrossing with red rice. To fully understand the interaction effects of these factors on outcrossing with red rice, controlled experiments are needed.

Regulations in the United States require animal biosafety level 3 (ABSL-3) or biosafety level 3 agriculture (BSL-3-Ag) containment for many endemic zoonotic pathogens and etiologic agents of foreign animal diseases. In an effort to protect public health, billions of dollars were invested in regulatory programs over many years to reduce the prevalence of zoonotic pathogens such as Brucella and Mycobacterium bovis in domestic livestock. In addition to research needs in domestic livestock hosts, the establishment of brucellosis and tuberculosis in wildlife in the United States has created a need for research studies addressing these zoonotic diseases. As guidelines in the Biosafety in Microbiological and Biomedical Laboratories (BMBL, 2009) for BSL-3 and BSL-3-Ag facilities are primarily directed toward laboratory or vivarium facilities, additional issues should be considered in designing large animal containment facilities for domestic livestock and/or wildlife. Flight distance, herd orientation, social needs, aggressiveness, and predictability are all factors we considered on a species by species basis for designing our containment facilities and for work practices with large ruminants. Although safety risk cannot be completely eliminated when working with large animals, studies in natural hosts are critical for advancing vaccine and diagnostic development, and providing basic knowledge of disease pathogenesis in natural hosts. Data gathered in these types of studies are vital for state and national regulatory personnel in their efforts to design strategies to control or eradicate diseases such as brucellosis and tuberculosis in their natural hosts, whether it is domestic livestock or wildlife. It is likely that failure to address the prevalence of disease in wildlife reservoirs will lead to re-emergence in domestic livestock. The overall benefit of these studies is to protect public health, provide economic benefits to producers, and protect the economic investment made in regulatory programs.

Regulators are acutely aware of the need for meaningful risk assessments to supportdecisions on the safety of GM crops to non-target invertebrates in determining theirsuitability for field release. We describe a process for developing appropriate, testablerisk hypotheses for invertebrates in agroecosystems that might be exposed to plantsdeveloped by GM and future novel technologies. An existing model (PRONTI) generates aranked list of invertebrate species for biosafety testing by accessing a database ofbiological, ecological and food web information about species which occur in croppingenvironments and their potential interactions with a particular stressor (EcoInvertebase). Our objective in this contribution is to explore and further utilise theseresources to assist in the process of problem formulation by identifying potentiallysignificant effects of the stressor on the invertebrate community and the ecosystemservices they provide. We propose that for high ranking species, a conceptual food webusing information in Eco Invertebase is constructed, and using an accepted regulatory riskanalysis framework, the likelihood of risk, and magnitude of impact for each link in thefood web is evaluated. Using as filters only those risks evaluated as likely to extremelylikely, and the magnitude of an effect being considered as moderate to massive, the mostsignificant potential effects can be identified. A stepwise approach is suggested todevelop a sequence of appropriate tests. The GM ryegrass plant used as the “stressor” inthis study has been modified to increase triacylglyceride levels in foliage by 100% toincrease the metabolisable energy content of forage for grazing animals. The high-ranking“test” species chosen to illustrate the concept are New Zealand native speciesWiseana cervinata (Walker) (Lepidoptera: Hepialidae),Persectania aversa (Walker) (Lepidoptera: Noctuidae), and theself-introduced grey field slug, Deroceras reticulatum (Müller).

Determining the effects of genetically modified (GM) crops on non-target organisms is essential as many non-target species provide important ecological functions. However, it is simply not possible to collect field data on more than a few potential non-target species present in the receiving environment of a GM crop. While risk assessment must be rigorous, new approaches are necessary to improve the efficiency of the process. Utilisation of published information and existing data on the phenology and population dynamics of test species in the field can be combined with limited amounts of experimental biosafety data to predict possible outcomes on species persistence. This paper presents an example of an approach where data from laboratory experiments and field studies on phenology are combined using predictive modelling. Using the New Zealand native weevil species Nicaeana cervina as a case study, we could predict that oviposition rates of the weevil feeding on a GM ryegrass could be reduced by up to 30% without threat to populations of the weevil in pastoral ecosystems. In addition, an experimentally established correlation between feeding level and oviposition led to the prediction that a consistent reduction in feeding of 50% or higher indicated a significant risk to the species and could potentially lead to local extinctions. This approach to biosafety risk assessment, maximising the use of pre-existing field and laboratory data on non-target species, can make an important contribution to informed decision-making by regulatory authorities and developers of new technologies.

Several biological containment methods have been developed to reduce pollen dispersal; many of them only have a proof of concept in a model plant species. This review focuses on biological containment measures which were tested for their long-term efficiency at the greenhouse or field scale level, i.e. plastid transformation, transgene excission, cleistogamy and cytoplasmic male sterility (CMS). Pollen-mediated gene transfer in transplastomic tobacco could occur at very low frequencies if the predominant mode of inheritance is maternal. Transgene excision from tobacco pollen can be made highly efficient by coexpression of two recombinases. For cleistogamous oilseed rape it was shown that some flowers were partially open depending on genotypes, environment and recording dates. Reports on the stability of CMS in maize and sunflower indicated that there is a high variability for different genotypes under different environmental conditions and over successive years. But for both crop types some stable lines could be selected. These data demonstrate that the biological containment methods discussed are very promising for reducing gene flow but that no single containment strategy provides 100% reduction. However, the necessary efficiency of biological containment methods depends on the level of containment required. The containment level may need to be higher for safety purposes (e.g. production of special plant-made pharmaceuticals), while much lower containment levels may already be sufficient to reach coexistence goals. It is concluded that where pollen-mediated gene flow must be prevented altogether, combinations of complementary containment systems will be required.

Prunus species are important commercial fruit (plums, apricot, peach and cherries), nut (almond) and ornamental trees cultivated broadly worldwide. This review compiles information from available literature on Prunus species in regard to gene flow and hybridization within this complex of species. The review serves as a resource for environmental risk assessment related to pollen mediated gene flow and the release of transgenic Prunus. It reveals that Prunus species, especially plums and cherries show high potential for transgene flow. A range of characteristics including; genetic diversity, genetic bridging capacity, inter- and intra-specific genetic compatibility, self sterility (in most species), high frequency of open pollination, insect assisted pollination, perennial nature, complex phenotypic architecture (canopy height, heterogeneous crown, number of flowers produced in an individual plant), tendency to escape from cultivation, and the existence of ornamental and road side Prunus species suggest that there is a tremendous and complicated ability for pollen mediated gene movement among Prunus species. Ploidy differences among Prunus species do not necessarily provide genetic segregation. The characteristics of Prunu s species highlight the complexity of maintaining coexistence between GM and non-GM Prunus if there were commercial production of GM Prunus species. The results of this review suggest that the commercialization of one GM Prunus species can create coexistence issues for commercial non-GM Prunus production. Despite advances in molecular markers and genetic analysis in agroecology, there remains limited information on the ecological diversity, metapopulation nature, population dynamics, and direct measures of gene flow among different subgenera represented in the Prunus genus. Robust environmental impact, biosafety and coexistence assessments for GM Prunus species will require better understanding of the mechanisms of gene flow and hybridization among species within the Prunus species complex.

This study assessed the impact of Pinus radiata (D. Don) genetically modified (GM) by biolistic insertion of the LEAFY and nptII genes on rhizosphere microbial communities of field grown trees. Rhizosphere soil was sampled quarterly for two consecutive years. A culture-independent approach was used to characterise the microbial communities based on PCR and denaturing gradient gel electrophoresis (DGGE) of 16S/18S rDNA gene fragments, and internal transcribed spacer (ITS) fragments amplified from total rhizosphere DNA. Trees from two independent transformation events were sampled, together with non-modified control trees of the same parental genotype. DGGE profiles of rhizosphere general Bacteria did not differ between GM and control trees with one exception (summer 2006 sample). For Alphaproteo- and Actinobacteria, significant differences between treatments were detected in one out of eight samplings. Small seasonal shifts could be detected in all bacterial communities. General fungal and ectomycorrhizal communities did not differ significantly between GM and control trees with the exception of summer 2006, when ectomycorrhizal communities associated with GM trees from one transformation event differed from those associated with control trees. Small seasonal shifts of general fungal and ectomycorrhizal communities were seen over the two-year sampling period. More detailed analysis of microbial communities at one sampling date (using amplified rDNA restriction analysis (ARDRA) and 16S/18S rDNA sequencing) revealed significant differences in four ARDRA groups between one GM treatment and the control (bacteria), and significant differences in one ARDRA group between the two GM treatments (fungi). When data from all sampling dates are considered together, the low incidence of statistical differences in the microbial communities associated with the genetically modified and control trees suggests that there was no significant impact of this genetic modification on rhizosphere microbial communities.

It is emerging that benefits of new innovations in agricultural biotechnology may not be realised without appropriate biosafety regulatory mechanisms. The Kenyan regulatory experiences related to regulation of genetically engineered (GE) agricultural activities are explored to provide some basis for defining the challenges involved in biosafety regulation. The various shortcomings in the way the Kenyan biosafety process has been implemented are consistent with the way regulatory systems have been evolving in Africa. The proposed adoption of a “smart regulation” provides the basis for a learning process through which subsequent biotechnology policy initiatives can be improved.

Development of transgenic triticale as a platform for novel bio-industrial products is predicated on an environmental biosafety assessment that quantifies the potential risks associated with its release. Pollen-mediated gene flow to related species and conventional triticale varieties is one pathway for transgene movement. A tier 1 quantification of triticale hybridization was conducted by emasculating and hand pollinating flowers under greenhouse conditions. Approximately 2000 manual pollinations were conducted for each cross and its reciprocal between two triticale genotypes: a modern triticale cultivar (AC Alta) and primary triticale (89TT108), and common wheat, durum wheat and rye. The frequency of outcrossing, hybrid seed appearance and weight, and F1 emergence and fertility were recorded. Outcrossing, F1 emergence and fertility rates were high from crosses between triticale genotypes. Outcrossing in inter-specific crosses was influenced by the species, and the genotype and gender of the triticale parent. In crosses to common and durum wheat where triticale was the male parent, outcrossing was ≥73.0% and ≥69.5%, respectively, but ≤23.9% and ≤3.0% when triticale was the female parent. Overall, outcrossing with rye was lower than with common and durum wheat. F1 hybrid emergence was greater when triticale was the female parent. With the exception of a single seed, all wheat-triticale F1 hybrid seeds were non-viable when triticale was the male parent in the cross. Only seven durum wheat-triticale F1 hybrids emerged from 163 seeds sown, and all were produced with triticale 89TT108 as female parent. With rye, 8 F1 hybrids emerged from 38 seeds sown, and all were produced from crosses to AC Alta; five with AC Alta as the female parent and three as the male. Interspecific F1 hybrids were self-sterile, with the exception of those produced in crosses between common wheat and triticale where triticale was the female parent. Tier 2 hybridization quantification will be conducted under field conditions.

Crops transformed to express Bacillus thuringiensis (Bt) toxins can cause close to 100% mortality of certain target pest species. This study assessed the effect of target pest reduction on the predatory insect Chrysoperla carnea (Stephens) in the presence of alternative prey. Numbers of lacewings recovered from Bt oilseed rape (cultivar Oscar, event O52) did not differ significantly from numbers of lacewings recovered from conventional oilseed rape in cage experiments with the target pest Plutella xylostella (Linnaeus) and the non-target pest Myzus persicae (Sulzer) when aphid densities were high. However, significantly fewer lacewings were recovered from Bt plants as aphid densities were lowered. Lacewing weights were not affected by plant type.

Whereas the capability of DNA uptake has been well established for numerous species and strains of bacteria grown in vitro, the broader distribution of natural transformability within bacterial communities remains largely unexplored. Here, we investigate the ability of bacterial isolates from the gut of grass grub larvae (Costelytra zealandica (White); Coleoptera: Scarabaeidae) to develop natural genetic competence in vitro. A total of 37 mostly species-divergent strains isolated from the gut of grass grub larvae were selected for spontaneous rifampicin-resistance. Genomic DNA was subsequently isolated from the resistant strains and exposed to sensitive strains grown individually using established filter transformation protocols. DNA isolated from wild-type strains was used as a control. None of the 37 isolates tested exhibited a frequency of conversion to rifampicin-resistance in the presence of DNA at rates that were significantly higher than the rate of spontaneous mutation to rifampicin-resistance in the presence of wild-type DNA (the limit of detection was approximately < 1 culturable transformant per 109 exposed bacteria). To further examine if conditions were conducive to bacterial DNA uptake in the grass grubs gut, we employed the competent bacterium Acinetobacter baylyi strain BD413 as a recipient species for in vivo studies. However, no transformants could be detected above the detection limit of 1 transformant per 103 cells, possibly due to low population density and limited growth of A. baylyi cells in grass grub guts. PCR analysis indicated that chromosomal AcinetobacterDNA remains detectable by PCR for up to 3 days after direct inoculation into the alimentary tract of grass grub larvae. Nevertheless, neither transforming activity of the DNA recovered from the alimentary tract of grass grubs larvae nor competence of bacterial cells recovered from inoculated larvae could be shown.

The introduction of genetically modified organisms (GMOs) has called for an improved understanding of the fate of DNA in various environments, because extracellular DNA may also be important for transferring genetic information between individuals and species. Accumulating nucleotide sequence data suggest that acquisition of foreign DNA by horizontal gene transfer (HGT) is of considerable importance in bacterial evolution. The uptake of extracellular DNA by natural transformation is one of several ways bacteria can acquire new genetic information given sufficient size, concentration and integrity of the DNA. We review studies on the release, breakdown and persistence of bacterial and plant DNA in soil, sediment and water, with a focus on the accessibility of the extracellular nucleic acids as substrate for competent bacteria. DNA fragments often persist over time in many environments, thereby facilitating their detection and characterization. Nevertheless, the long-term physical persistence of DNA fragments of limited size observed by PCR and Southern hybridization often contrasts with the short-term availability of extracellular DNA to competent bacteria studied in microcosms. The main factors leading to breakdown of extracellular DNA are presented. There is a need for improved methods for accurately determining the degradation routes and the persistence, integrity and potential for horizontal transfer of DNA released from various organisms throughout their lifecycles.

The OECD Blue Book, "Recombinant DNA: Safety Considerations" was published in 1986. The developed principles and concepts on the stepwise and case-by-case approach for risk assessment in the Blue Book have been used as a foundation for building national biosafety frameworks and international instruments for the regulation of the products of modern biotechnology. Twenty years after the Blue Book was published, OECD continues its activities on unique identifier systems, information-sharing, consensus documents for the biology of crops, trees and microorganisms with respect to harmonization of regulatory oversight and those of novel food and feed safety. These activities benefit, without any doubt, the international community at large, including OECD non-member countries. In order to strengthen its position in the international arena and to better respond to the needs of the changing world, OECD would be encouraged to participate in a more active manner in the technology transfer process and co-existence debate, together with continuing the organization's efforts on information-sharing and harmonization in the field of biotechnology and biosafety.

This study deals with hybrids between Aegilops geniculata and bread wheat, Triticum aestivum L., detected in two Ae. geniculata populations in the “Meseta Central”, Spain’s central plateau where wheat is a major crop. Morphological traits and pentaploid chromosome numbers were used to identify hybrids in 2004 and 2005. The frequency of hybridization under natural conditions was calculated for one of these populations. Six hybrids were detected from a sample of 3158 seeds from this population. The hybrids were mainly sterile but seed set can be found. This study extends the range of documented hybridization to include central Spain. The potential risks associated with natural hybridization in the context of transgenic wheat cultivation are discussed.